Assessment of the Equivalence of Technical Materials - European ...

1. Ascertainment of the necessity to conduct an assessment on the equivalence directlyafter receiving the application. It is of interest that the intention of a MS to conduct theequivalence assessment of a specific source appears in the table of ‘equivalent sourcesand compliance checks’ on CIRCA. Therefore, as soon as a MS (Rapporteur MemberState (RMS) or Designated Member State (DMS)) agrees to conduct an equivalenceassessment, this should be communicated to the responsible contact point 12 and COM(in copy) by e-mail together with a ‘completed row’ (Excel file template) containingthe relevant information on the application, in order to enable an update of the table.An up-to-date template can be found on CIRCA(https://circa.europa.eu/Members/irc/sanco/pest/library?l=/technical_evaluation/overview_tables/equivalence_templatexls/_EN_1.0_&a=d).2. The RMS/DMS has to prepare the report on equivalence within 60 days fromreceiving the application (This should include the possibility for the applicant tosubmit comments).3. The report has to be communicated to the COM, the other Member States and theapplicant. The report is placed on CIRCA. This is communicated to relevant contactpoints by e-mail together with the deadline for comments. However, theconfidentiality of business and trade secrets has to be guaranteed in cases where theapplicant under consideration is differrent to the one of the references source.4. Within 30 days the COM, the MS and the applicant should send their comments to theDMS/RMS.5.1 In the case of a positive conclusion on equivalence and where no objection to thisconclusion has been raised, the conclusion should be communicated within 10 daysafter the deadline (for commenting) to the COM and the Member States. If required,the initial report on CIRCA is replaced by a revised version that takes into account thecomments received. For the report the following naming convention should be usedwhen uploading on CIRCA: “active substance equivalence Notifier Source (City) MSDate "draft" resp. "final".A reporting table that summarizes all comments on the equivalence report should beuploaded on CIRCA (in the same folder as the equivalence report). Each commentshould be addressed by the RMS/DMS and non-adoption of comments should beproperly justified.12 The e-mail should be sent to equivalence@health.belgium.be. Please be sure to use the proper template (seeCIRCA).17